Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Phase 3CompletedNCT02090764

Ferrer Internacional S.A.412 enrolled

Overview

This is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

412

Conditions

Impetigo

Interventions

OzenoxacinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 2 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area. * Total Skin Infection Rating Scale (SIRS) score of at least 3, including pus/exudate score of at least 1 Exclusion Criteria: * Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. * Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)

Locations (1)

Caparra Internal Medicine Center

Rio Grande, Puerto Rico

Outcomes

Primary Outcomes

Clinical Success

Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population. Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary. The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain.

Time frame: Visit 3 (Day 6-7)

Data from ClinicalTrials.gov

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